(96 days)
The Delta CTA™ Humeral Cups, as part of the DePuy Delta CTA™ Total Shoulder are intended for use in patients with non-functional rotator cuffs with or without bone cement.
The Delta CTA™ Total Shoulder Prosthesis is indicated for use in grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
The Delta CTA™ Humeral Cups proposed in this submission are a line extension to the humeral cup system components cleared in the DePuy Delta CTA™ Shoulder submission (cleared as DePuy Delta Shoulder under K021478, November 18, 2003). The additional humeral cups are made of polyethylene and will be available in four sizes: 36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness.
This 510(k) premarket notification for the Delta CTA™ Humeral Cups does not describe a study involving acceptance criteria or device performance.
Instead, this submission is centered on demonstrating substantial equivalence to a previously cleared device (DePuy Delta CTA™ Shoulder, K021478). The "study" described, therefore, is a comparison to the predicate device, not a performance study against specific acceptance criteria.
Here's why and what information is available:
1. Acceptance Criteria and Reported Device Performance:
- Not Applicable: The submission does not define specific acceptance criteria related to clinical performance (e.g., accuracy, sensitivity, specificity, or clinical outcomes) for the Humeral Cups. The "performance" being evaluated is the similarity of the new device to the predicate.
2. Sample Size and Data Provenance:
- Not Applicable: No clinical or in-vitro study data with a "test set" and a defined sample size are provided. The basis for substantial equivalence is the design, material, and manufacturing method.
3. Number of Experts and Qualifications for Ground Truth:
- Not Applicable: Since no clinical performance study was conducted to establish ground truth, there were no experts employed for this purpose in this submission.
4. Adjudication Method:
- Not Applicable: No adjudication method was used as there was no study requiring one.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No: An MRMC comparative effectiveness study was not performed. This type of study investigates the impact of an AI device on human reader performance, which is not relevant to a medical implant that is not an AI-enabled diagnostic or therapeutic device.
6. Standalone Performance Study:
- No: A standalone (algorithm-only) performance study was not performed. The device is a physical implant, not an algorithm.
7. Type of Ground Truth Used:
- Not Applicable: No "ground truth" in the context of a diagnostic or therapeutic study was established or used. The "ground truth" for substantial equivalence is the existing predicate device and its established safety and effectiveness.
8. Sample Size for the Training Set:
- Not Applicable: The device is a physical implant, not an AI model, so there is no "training set."
9. How Ground Truth for the Training Set was Established:
- Not Applicable: As above, there is no training set for this device.
Summary of the Basis for Substantial Equivalence (from the provided text):
The submission argues for substantial equivalence based on the following:
- Identical Design, Material, and Manufacturing Method: The Humeral Cups proposed are identical in these aspects to those cleared in the predicate device (Delta CTA™ Total Shoulder Prosthesis, K021478).
- Line Extension/Increased Sizes: The current submission only introduces additional sizes (36mm diameter + 3mm thickness, 36mm diameter + 9mm thickness, 42mm diameter + 3mm thickness and 42mm diameter + 9mm thickness) to the existing range of humeral cups, which were already cleared in 36mm diameters in +0mm and +6mm thicknesses, and 42mm diameters in +0mm and +6mm thicknesses.
Therefore, the "study" demonstrating the device meets "acceptance criteria" here is the presented rationale that the new sizes of humeral cups do not introduce new questions of safety or effectiveness compared to the already cleared predicate device, given the identical design, materials, and manufacturing processes. The FDA's letter (sections 2 and 3) indicates their agreement with this assessment, leading to the clearance of the device.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”